Iterum Therapeutics (ITRM)

[exwannabe]

Why the huge up swings and heavy reversals?

Microcap bio while digesting news.

I am bit surprised the PPS has not reacted better. The results are solid wrt approval.

On the commercial side the results we have not yet seen are important. The entire patient population includes patients who should respond well to both drugs (the m-MITT population) and patients who might not (non m-MITT) . The results presented only the former (per the agreed SPA with the FDA). But commercially the full trial (ITT) matters.

On the non- m-MITT patients all they have is disclosed is not stat sig due to insufficient patients. That to me implies it trended positive, but not much. If so, then we know the full trial was decent, though almost certainly not stat sig as they would have PR'd that.

They do not need stat sig on the ITT to gain approval. They do need it for the label to reflect the use. And that is the commercial issue which is offsetting the approval news and causing the choppy PPS, IMO.